Ossur recalls LIL Angel Vest P2 and P3 models (2009-2018) due to incorrect titanium pin label description. Affected units may have ceramic tip listed instead of titanium pin.
Halo system products labeled MR conditional will undergo confirmatory safety testing to confirm MR conditional parameters. In addition, the second line description on the titanium pin label mistakenly lists ceramic tip. The second line description should state titanium pin.
Ossur is recalling LIL Angel Vest P2 and P3 models produced between June 2009 and December 2018 because the titanium pin label incorrectly states ceramic tip instead of titanium pin. This labeling error could lead to confusion about the product's compatibility with MRI machines.
The titanium pin label on these vests mistakenly lists ceramic tip instead of titanium pin. This error could cause confusion about the product's MRI compatibility, potentially leading to incorrect use in MRI scans. However, the recall does not indicate immediate safety risks to users.
Owners of LIL Angel Vest P2 and P3 models with part numbers starting with 545100 or 545150 manufactured from June 2009 to December 2018 are affected. Patients using these vests for MRI compatibility are most at risk due to potential labeling confusion.
Check for part numbers starting with 545100K, 545100L, 545100S, 545150K, 545150L, or 545150S on the product. The vests were manufactured between June 30, 2009, and December 13, 2018.
Look for part numbers starting with 545100 or 545150 on the vest.
The titanium pin label incorrectly states ceramic tip instead of titanium pin, which could cause confusion about MRI compatibility.
No, the recall does not require stopping use. The issue is a labeling error that may affect MRI compatibility, but no immediate safety risk is described.
The official recall notice does not specify a remedy, so no action is required beyond checking the product label.
We’ve drafted a message you can send Ossur to request your refund or repair — edit it as you like.
Subject: Recall Z-1004-2019 — Ossur Ossur Hello, I own a Ossur that is covered by recall Z-1004-2019 from Ossur. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
